ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition, 2nd Edition (Hardback) book cover

ISO 13485:2016

A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

By Itay Abuhav

CRC Press

878 pages | 50 Color Illus.

Purchasing Options:$ = USD
Hardback: 9781138039179
pub: 2018-05-15
eBook (VitalSource) : 9781351000796
pub: 2018-05-11
from $74.98

FREE Standard Shipping!


This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.

Table of Contents

Scope, Normative References. Terms and Definitions. Context of the Organization. Understanding the Organization and its Context. Understanding the Needs and Explanations of Interested Parties. Determining the Scope for the Quality Management System. Quality Management System and its Processing. Leadership. General Customer Focus. Policy. Establishing the Quality Policy. Communicating the Quality Policy. Organizational Roles, Responsibilities and Authorities. Planning. Actions to Address Risks and Opportunities. Qualty Objectives and Planning to Achieve Them. Planning of Changes. Support. Resources. General. People. Infrastructure. Environment for the Operation of Processes. Monitoring and Measuring Resources. Organizational Knowledge. Competence. Awareness. Communication. Documented information. General. Creating and Updating. Control of Documented Information. Operation. Operational Planning and Control. Requirements for Products and Services. Customer Communication. Determining the Requirements for Products and Services. Review of Their Requirements for Products and Services.Changes to Requirements for Products and Services. General. Design and Development Planning. Design and Development Inputs. Design and Development Controls. Design and Development Outputs. Design and Development Changes.

About the Author

Itay Abuhav is a highly experienced medical device quality control expert and consultant, based in Geneva, Switzerland. He has over 25 years in dealing directly with a number of large medical device enterprises, in their quality control manufacturing processes of state-of-the art medical devices. He also has been awarded 15 patents in medical devices and related technologies.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Biotechnology